Pivotal Clinical Trials (conducted under Good Clinical Practices, GCP)
Activities in support of GCP studies include:
- Helping Sponsors design a development plan and negotiate the plan with the CVM.
- Developing or assisting with development of protocols and case report forms
- Preparing and producing Investigator manuals, casebooks, owner diaries and supporting materials
- Developing study specific SOPs (Standard Operating Procedures) in consultation with the Sponsor
- Identifying, qualifying, and training investigators
- Monitoring and project-managing the trial
- Managing clinical trial material (test article)
- Reporting and managing adverse events
- Data management
- Statistical services
- Quality Control and Quality Assurance services
- Writing Final Reports
- Coordinating the regulatory submission process, including pagination, copying, assembling and shipping
- Writing and editing the FOI summary and proposed label language
- Communicating and negotiating with the FDA Center for Veterinary Medicine
To request more information on AlcheraBio’s Contract Research services in the area of GCP trials, please click here.